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Retrospective and Prospective Study on Professional Continuous Glucose Monitoring in Insulin-treated Type 2 Diabetes

NCT04141111 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2019-10-28

No results posted yet for this study

Summary

In people with type 2 diabetes (T2D) without adequate glycemic control for an extended period of time, continuous glucose monitoring (CGM) can provide detailed information about daily glycemic profile facilitating therapeutic adjustments decision which can contribute to an improvement of glycemic control and overall health status.

The ADJUST study aims to evaluate the impact of CGM systems' use on clinical decision and glycemic control of people with badly controlled T2D, already under insulin therapy.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DEVICE

Continuous Glucose Monitoring (CGM)

On each visit (baseline, 4, 8, and 12 months), participants received an iPro2 CGM device (MiniMed Medtronic), placed according to the manufacturer's standard procedure. The iPro2 was used each time for 7-days. During this period, patients were asked to perform 4 SMBG measurements daily for calibration (fasting, lunch, dinner, and before bed). Patients received a diary to register food intake, physical activity and medication, SMBG values, and any diabetes-related event (extra consultations, phone calls, etc) in the previous 4 months. Each time, CGM data was interpreted by an expert clinician, and a report was delivered, within one week, to the respective healthcare team. This report was discussed together by the patient and one member of the healthcare team, either in consultation or by phone, agreeing on any necessary therapeutic changes. If necessary, extra consultations for nutrition, nursing, or education, were scheduled, to address specific needs identified during rCGM review.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Associacao Protectora dos Diabeticos de Portugal

    lead OTHER

Principal Investigators

  • Joao Raposo, MD PhD · Associacao Protectora dos Diabeticos de Portugal

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-22
Primary Completion
2017-01-24
Completion
2018-03-01
FDA Device
Yes

Countries

  • Portugal

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04141111 on ClinicalTrials.gov